BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    MDR report key: 2827566 · Received November 9, 2012

    Report

    Report Number
    2910081-2012-09393
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    MUJ
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED OCCURRENCE SHOWED THAT THIS IS A SOFTWARE ERROR OF THE VSIM APPLICATION. THE PROBLEM OCCURS IF THE USER SELECTS ONE OF THE PRE-DEFINED STRUCTURE NAMES IN THE NAME DROPDOWN IN THE STRUCTURE OPERATIONS DIALOG (BOOLEAN OPERATION). A WORKAROUND HAS BEEN PROVIDED TO THE CUSTOMER. THE USER HAS BEEN INFORMED TO TYPE IN A NAME INSTEAD OF ACCEPTING THE SELECTED VALUE FROM THE PRESETS. THE NAME WILL BE STORED CORRECTLY AS SOON AS IT IS TYPED. CONSIDERING THIS, NO ADDITIONAL CORRECTIVE ACTION IS REQUIRED. BRAND NAME - SYNGO SUITE FOR ONCOLOGY SYSTEM IS A COLLECTION OF DEVICES WITH COMPATIBLE WORKFLOWS. THE SUBJECT DEVICES ARE LISTED AS: SYNGO RT DOSIMETRIST 2.7, SYNGO RT ONCOLOGIST 4.2. 510K NUMBERS FOR BOTH DEVICES OF SYNGO SUITE FOR ONCOLOGY SYSTEM: K101119 - SYNGO DOSIMETRIST WORKSPACE V2.7, K103606 - SYNGO ONCOLOGIST V4.2.

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(4) 2012 THAT THE CUSTOMER IS EXPERIENCING A REOCCURRING PROBLEM ON THE DOSIMETRIST 2.7 AS WELL AS THE ONCOLOGIST 4.2 WITH SEGMENTATION. REPORTEDLY, WHEN THEY MERGE TWO (2) CONTOURS, E.G. LEFT AND RIGHT LUNG TO ONE (1) NEW CONTOUR, THE NEW CONTOUR GETS THE EXACT SAME NAME AS THE FIRST CONTOUR INSTEAD OF THE NEW NAME IT IS GIVEN DURING THE MERGE (E.G. "LEFT LUNG" INSTEAD OF "LUNG ALL"). THE CUSTOMER FEELS THAT THIS ISSUE COULD LEAD TO INCORRECT PLANNING IF TWO (2) CONTOURS HAVE THE SAME NAME THAT CAN EASILY BE MIXED UP. THERE IS NO REPORT OF INJURY TO A PATIENT. THIS REPORTED ISSUE HAS OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNGO SUITE FOR ONCOLOGY SYSTEM SYSTEM, PLANNING, RADIATION THERAPY TREATMENT MUJ SIEMENS MEDICAL SOLUTIONS USA, INC. 10568604

    Patients

    Seq Age Sex Outcome Treatment
    1